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DRUG:

Yescarta (axicabtagene ciloleucel)

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Other names: KTE-C19 CAR, anti-CD19 chimeric antigen receptor transduced T cells, KTEC19, KTE-C19, KTE-C19 chimeric antigen receptor T cell therapy, FKC876, FKC-876, anti-CD19-CAR PBL, anti-cluster of differentiation 19 (CD19)-CAR PBL, FKC 876
Company:
Cabaret Biotech, Fosun Kite, Gilead, National Cancer Institute
Drug class:
CD19-targeted CAR-T immunotherapy
Related drugs:
2d
New P2 trial
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TP53 (Tumor protein P53) • BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
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TP53 mutation
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cytarabine • Yescarta (axicabtagene ciloleucel) • carmustine • melphalan
5d
Case Report: Transverse myelitis following CAR-T cell therapy for post-transplant lymphoproliferative disorder. (PubMed, Front Immunol)
We report a case of severe, irreversible transverse myelitis following CD19-directed CAR-T cell therapy (axicabtagene ciloleucel) for refractory post-transplant lymphoproliferative disorder (PTLD) in a young female lung-transplant recipient...We further address diagnostic challenges, and review current management strategies such as corticosteroids, IL-1 blockade, and IL-6 neutralization. This report underscores the need for heightened vigilance, early imaging, and systematic reporting to improve prevention and treatment of this rare but severe CAR-T-related neurotoxicity.
Journal
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IL6 (Interleukin 6) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • CCL2 (Chemokine (C-C motif) ligand 2) • IL18 (Interleukin 18)
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Yescarta (axicabtagene ciloleucel)
7d
Enrollment closed
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Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • Yescarta (axicabtagene ciloleucel) • prednisone • fludarabine IV
12d
Impaired hematopoiesis affects apheresis and CAR T-cell product composition and treatment response. (PubMed, Transfusion)
These findings highlight the importance of early leukapheresis, ideally before intensive treatments, to optimize T-cell yield, product quality, and therapeutic efficacy.
Journal
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CD8 (cluster of differentiation 8)
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Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T) • HD-CAR-1
21d
Circulating CAR T-Cells After Treatment With Axicabtagene Ciloleucel in Patients With Relapsed/Refractory Aggressive B-Cell Lymphomas and Its Association to Treatment Outcome. (PubMed, Eur J Haematol)
Our study indicates that CAR T-cell levels after axi-cel correlate to durable response, progression-free survival, and that expansion of CD8+ CAR T-cells might be of specific importance for efficacy. Potentially, CAR T-cell levels may be used to enable early detection of patients with high risk of CAR T-cell treatment failure.
Journal
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CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
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Yescarta (axicabtagene ciloleucel)
28d
New P4 trial
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cyclophosphamide • Yescarta (axicabtagene ciloleucel) • Kymriah (tisagenlecleucel-T) • fludarabine IV • Tecartus (brexucabtagene autoleucel) • Carvykti (ciltacabtagene autoleucel)
1m
New P3 trial
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cyclophosphamide • Yescarta (axicabtagene ciloleucel) • fludarabine IV
2ms
Non-ICANS neurotoxicities CD19-directed CAR T-cell therapy and the emergence of movement and neurocognitive treatment-emergent adverse events: a case report. (PubMed, Front Immunol)
We report a 63-year-old male patient with diffuse large B-cell lymphoma (DLBCL) who developed delayed-onset neurotoxicity on day +22 following CD19-directed CAR T-cell therapy with axicabtagene ciloleucel (axi-cel), after an initial episode of CRS and ICANS...Follow-up neuropsychological testing revealed persistent deficits in attention and processing speed. This case broadens the known neurotoxicity spectrum of CAR T-cell therapies and underscores the need for heightened clinical vigilance and refined diagnostic criteria beyond ICANS, even in CD19-targeted settings.
Journal • Adverse events
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CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CD38 (CD38 Molecule) • NEFL (Neurofilament Light Chain)
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Yescarta (axicabtagene ciloleucel)
2ms
Fecal Microbiome Transplant to Remodel Intestinal Microbiota for Patients With Relapsed or Refractory Lymphoma With Exposure to High-Risk Antibiotics Who Are Receiving Chimeric Antigen Receptor T Cells (clinicaltrials.gov)
P2, N=56, Recruiting, City of Hope Medical Center | Not yet recruiting --> Recruiting | Trial completion date: Apr 2028 --> Jan 2029 | Trial primary completion date: Apr 2028 --> Jan 2029
Enrollment open • Trial completion date • Trial primary completion date
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BCL2 (B-cell CLL/lymphoma 2)
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Yescarta (axicabtagene ciloleucel)
2ms
Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy (clinicaltrials.gov)
P2, N=27, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial primary completion date: Jan 2026 --> Jun 2026
Trial primary completion date
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JAK1 (Janus Kinase 1) • CRP (C-reactive protein)
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Yescarta (axicabtagene ciloleucel) • itacitinib (INCB039110)
2ms
Anakinra in Preventing Severe Chimeric Antigen Receptor T-Cell Related Encephalopathy Syndrome in Patients With Recurrent or Refractory Large B-cell Lymphoma (clinicaltrials.gov)
P2, N=23, Terminated, Jonsson Comprehensive Cancer Center | Trial completion date: Jun 2027 --> Feb 2026 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2026 --> Feb 2026; slow accrual
Trial completion date • Trial termination • Trial primary completion date
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cyclophosphamide • Yescarta (axicabtagene ciloleucel) • fludarabine IV • Kineret (anakinra)
2ms
New P1/2 trial
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Yescarta (axicabtagene ciloleucel)